QbD and GMPs: How the Convergence of Science and Compliance Will Change the Way We Work

[...] particularly those who actually determine the design space, it means familiarity with the advanced statistical methods that are used to map the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy, and to determine the various perm...

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Veröffentlicht in:	Biopharm International 2009-11, Vol.22 (11), p.22
Hauptverfasser:	Meyers, Chester A, Weigl, Debbie
Format:	Magazinearticle
Sprache:	eng
Schlagworte:	Biological products Compliance Design of experiments Good Manufacturing Practice Manufacturing Pharmaceutical industry Process controls Product quality Product testing Quality control Science Statistical methods Studies
Online-Zugang:	Volltext
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